A randomized multicenter study of carboplatin-gemcitabine versus carboplatin-paclitaxel in elderly patients with non-small cell lung cancer with emphasis on geriatric assessment and quality of life: The NVALT-3 study.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR925
• Date of registration: 05/03/2007
• Primary sponsor: NVALT
• Public title: A randomized multicenter study of carboplatin-gemcitabine versus carboplatin-paclitaxel in elderly patients with non-small cell lung cancer with emphasis on geriatric assessment and quality of life: The NVALT-3 study.
• Scientific title: A randomized multicenter study of carboplatin-gemcitabine versus carboplatin-paclitaxel in elderly patients with non-small cell lung cancer with emphasis on geriatric assessment and quality of life: The NVALT-3 study. - Chemotherapy in elderly patients
• Date of first enrolment: 1/3/2003
• Target sample size: 182
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=925
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: A.N.M. Wymenga

• Name: A.N.M. Wymenga

Key inclusion & exclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed inoperable (stage III) or disseminated (stage IV) non small cell lung cancer;

2. No previous chemo- and or radiotherapy;

3. Age =/> 70 years;

4. WHO performance status =/< 2;

5. Estimated life-expectancy of concomitant diseases for at least six months;

6. Measurable disease on physical examination, chest X-ray, or CT-scan;

7. Adequate bone marrow reserve: Leukocytes =/> 3.0 x 109/L, neutrophils =/> 1.5 x 109/L, platelets =/> 100 x 109/L;

8. Adequate renal function: creatinine clearance =/> 50 mL/min (Cockcroft formula);

9. Adequate liver function: serum aspartate aminotransferase (ASAT/SGOT) and serum alanine aminotransferase (ALAT/SGPT) less than 1.5 times the upper normal limit for the institution, total serum bilirubin within the normal limits for the institution, alkaline phosphatase less than 5 times the upper normal limit for the institution (unless bone metastases are present in the absence of any liver disease);

10. Patients must understand the study, be willing to comply with the scheduled visits and give written informed consent before starting the study.
Exclusion criteria: 1. Patients with a mixed form of NSCLC and SCLC;

2. Active uncontrolled infection;

3. Presence of CNS metastases;

4. Symptomatic sensory peripheral neuropathy =/> grade 1 according to NCIC Common Toxicity Criteria;

5. Patients with uncorrected hypercalcemia;

6. Unstable peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids;

7. Unstable cardiac conditions;

8. Concomitant administration to any other experimental drugs under investigation.

However, patients should continue on their usual medications.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Non small cell lung cancer (NSCLC)

Intervention(s)

Arm 1: Carboplatin AUC 5 mg/ml/min on day 1 - gemcitabine 1250 mg/m2 on days 1 and 8 of a three week cycle, for a maximum of 4 cycles.

Arm 2: Carboplatin AUC 5 mg/ml/min on day 1 - paclitaxel 175 mg/m2 on day 1 of a three week cycle, for a maximum of 4 cycles.

Carboplatin dose will be calculated according to the Calvert formula
Pretreatment a comprehensive geriatric assessment (CGA) will be performed by a specialized research nurse.

Primary Outcome(s)

To compare changes in quality of life between the two treatment groups from baseline as compared with quality of life at 18 weeks after start treatment.

Secondary Outcome(s)

1. Toxicity of both treatment arms;

2. Response rate in each treatment arm;

3. Survival of both treatment arms (overall survival, median survival, 1 year survival as well as progression free survival);

4. Geriatric assessments and serial assessments of quality of life and looking at:

a. Are there determinants in the CGA that could be used as a tool to predict which patients benefit from chemotherapy in terms of improvement in quality of life and experienced toxicity;

b. Is there a correlation between the GFI and the Karnofsky score and/or performance score according to WHO?;

c. Is there a correlation between GFI and toxicity of therapy?;

d. Is there a correlation between GFI and response to therapy?;

e. Is there a difference in baseline scores in CGA/GFI in patients accepting chemotherapy between an university hospital or general hospital? (indication for referral filter);

f. Does tumor response correlate with (changes in) global quality of life?;

5. The utilization of health care resources will be prospectively studied by counting the number of hospital days.

Secondary ID(s)

incomplete

N/A

Source(s) of Monetary Support

Amgen, Eli Lilly Nederland B.V.